Editor’s note: This story is part of our 2022 PharmaVoice 100 feature.
Dr. Penelope Manasco, CEO of MANA RBM, has dedicated the past decade to advancing the way technology can make clinical trials more effective and efficient, funding groundbreaking research and proving that there’s a better way forward.
But the thing that keeps her up at night is how to spread the word.
“I struggle with how to better disseminate our innovations,” she says. “Our work is critical to improving how we conduct clinical trials but changing ingrained ideas or even starting the dialogue about innovation is my biggest challenge.”
That desire to share innovations with the broader community is at the heart of MANA RBM, a clinical trials institute and research laboratory. As her nominator writes, her “passion is in researching the research enterprise.”
“Penny does not create things for the betterment of her company,” her nominator wrote. “She makes them with the explicit intent of sharing them with the clinical research community.”
At the core of MANA RBM is REACHER, a patent-pending clinical analytic suite, which Manasco describes as a “completely new clinical trials software system that is technology agnostic, aggregates data (without normalization) across all clinical data systems, automatically analyzes that data and announces action-oriented results specific to a user.”
“It is the next wave of innovation in clinical research because it actively conducts analysis without waiting for someone to open the software,” Manasco says. “It allows automated monitoring, including identifying errors that matter — finding errors that cannot be found manually. It improves quality, saves time and decreases the amount of staff needed to run a trial.”
Her nominator has seen this firsthand as they’ve worked together for three years on a large phase 3 oncology drug-in-patient trial, which has operationalized “an innovative and completely digital approach to conducting this trial across 20+ large tertiary communities and selected academic research centers.”
According to her nominator, REACHER “identifies errors in trial conduct that could not be identified with traditional manual monitoring approaches. By being able to automatically identify [more than] 300 different data combinations that would render a subject ineligible for our study, MANA is able to prevent errors that would put patients at risk.”
As a National Institutes of Health-trained physician scientist, Manasco’s career has spanned roles at NIH, the Burroughs Wellcome fund, GlaxoWellcome, GSK and two clinical research software companies. In these roles she learned that technology offered a better way to conduct clinical trials.
“When I started MANA RBM a decade ago, I wanted to demonstrate the value of using technology to more efficiently conduct clinical research,” Manasco says. “We funded and published our own research into clinical trial operations to better test different methodologies. We developed software that was needed and have funneled the proceeds from our company to continue this research.”
“I will continue to advocate for the application of scientific rigor to clinical operations, technology and processes with the goal of improving clinical research for all stakeholders, participants and subjects.”
Dr. Penelope Manasco
CEO, MANA RBM
Now, the COVID-19 pandemic has opened people’s minds to the possibilities of a new way of working.
“If we can use this new open-mindedness to re-evaluate how we conduct trials and perform oversight, we can make huge strides in getting medicines to patients faster. If we can use scientific rigor to evaluate the methods that we use for every trial, we will reach our goal more efficiently and effectively,” Manasco says. “It isn't just one type of trial (decentralized or hybrid trials) that can benefit — all trials need to benefit from proven oversight methods.”
Manasco’s nominator notes that she isn’t just doing this work for herself, pointing to her work with MANA RBM’s free training program on YouTube.
“Manasco’s personal and professional goal is to teach others how to use innovative approaches to monitoring and trial management,” her nominator writes.
Manasco is also dedicated to paying it forward in other ways, too, that go far beyond herself or even her lifetime.
“My next act will be a nonprofit to train under-represented people to become the leaders of clinical trials operations in the future,” she says. “They will be armed with the additional training and skills including understanding data, technology and quality. They will also be armed with the skills to be leaders in the industry — taking the entire industry into the 21st century.”